Gastric cancer
Conditions
Interventions
Adjuvant chemotherapy (S-1 monotherapy followed by S-1+CDDP therapy followed by S-1 monotherapy)
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proved adenocarcinoma of stomach 2) >=D2 lymph node dissection, curability B 3) Stage IIIA/IIIB (Japanese classification) 4) ECOG performance status 0-1 5) Age between 20 and 75 years 6) No prior chemotherapy or radiotherapy 7) Able to be enrolled between 4 and 6 weeks after surgery 8) Enough oral food intake possible between 4 and 6 weeks after surgery 9) Adequate organ function 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1)synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2)pregnant or breast-feeding women 3)severe mental disease 4)systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 5)other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6)myocardial infarction within the past 6 months 7)Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment compliance with 3 courses of S-1 plus CDDP | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment compliance with 2 courses of S-1 plus CDDP, proportion of patients receiving treatment according to protocol, and adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Takahari
Aichi Cancer Center Hospital Medical Oncology
Outcome results
None listed